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The effect of Vitamin D Supplement in comparison whit placebo on insulin resistance and prevention of Diabetes Mellitus Type 2 in Patients with Pre-diabetes

Protocol summary

Summary
The purpose of study is to evaluate effect of Vitamin D Supplement on insulin resistance and the incidence of Type 2 Diabetes Mellitus in patients with prediabetes (IFG or IGT) and vitamin-D deficiency. This is a triple blinded placebo controlled clinical trial (researcher, patient, analyzer). The study population consists of all adult patients with pre-diabetes presenting to endocrinology clinic. Inclusion criteria include 18 years of age, pre diabetes, and vitamin-D deficiency. Exclusion criteria include patients with overt diabetes or other medical conditions that interfere with glucose metabolism, and chronic use of medications that interfere with glucose metabolism. 80 subjects will enroll in each group. Past medical history will be obtained and height, weight, waist circumference will be measured and Body Mass Index calculated for all participants. A blood sample will be drawn and FPG and serum insulin will be measured. Then 75-gr OGTT will be done. For evaluation of insulin resistance HOMA-IR index will be used. In vitamin D group, fifteen 50,000 IU Vitamin-D pearls will be administered weekly for 3 months then 1 pearl monthly. In the control group, placebo pearls will be administered with similar schedule. At the end of month 3 and 6 weight and waist circumference will be measured. The two groups will be compared regarding FPG, serum vitamin D, insulin resistance and OGTT results.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013050413223N1
Registration date: 2015-06-16, 1394/03/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-16, 1394/03/26
Registrant information
Name
Mahtab Niroomand
Name of organization / entity
Shahid Beheshty University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8826 2390
Email address
m.niroomand@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid BeheshtiUniversity of Medical Science
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Vitamin D Supplement in comparison whit placebo on insulin resistance and prevention of Diabetes Mellitus Type 2 in Patients with Pre-diabetes
Public title
The effect of Vitamin D Supplement on Insulin Resistance and Prevention of Diabetes Mellitus Type 2 in Patients with Pre-diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: adult patients who are over 18 years old; pre-diabetes (IFG or IGT) and vitamin-D deficiency; obtaine informed consent. Exclusion criteria: overt Diabetes Mellitus; condition which interfere with glucose metabolism (malignancy, CRF, , inflammatory disease...); diseases like thyroid disease or mal-absorption; take medication that interfere with glucose metabolism (Steroids, HRT,Diuretics).
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences, Ethics committee
Street address
Next to Ayatollah Taleghani Hospital, Velenjak
City
Tehran
Postal code
1985717443
Approval date
2013-02-24, 1391/12/06
Ethics committee reference number
131th Ethics committee

Health conditions studied

1

Description of health condition studied
pre-diabetes (IFG or IGT)
ICD-10 code
E11
ICD-10 code description
Impaired glucose toleranceR73.0Diabetes: chemical latent Impaired glucose tolerance Prediabetes

Primary outcomes

1

Description
Diabetes(75gr-OGTT):Assessment of fasting plasma glucose after at least 8-hours fasting then 2 hours after administration of 75 gram glucose, Insulin resistance evaluated by calculating HOMA-IR
Timepoint
Befor intervention, 3 and 6 months after intervention
Method of measurement
Fasting plasma sample for evaluation of FPG and Serum insulin,Oral glucose tolerance test(OGTT) with 75gr glucose

Secondary outcomes

1

Description
height, weight, BMI, weist circmfrence
Timepoint
Every 3 month
Method of measurement
height (cm), weight (kg), BMI (kg/squired meters), weist circmfrence(cm)

Intervention groups

1

Description
In Case Group/Vitamin D Group :Vitamin D will be administered as PO (15 Vitamin D pearls). In the first 3 months, the subjects will take one pearl (50,000 IU) every week. Then three pearls will be used for 3 months (one pearl monthly).
Category
Treatment - Drugs

2

Description
In the Control Group, placebo pearls (using paraffin and prepared by Zahravi Pharmaceutical Company) with the same size, shape, and color as the original ones will be administered as PO (15 Vitamin D pearls). In the first 3 months, the subjects will take one pearl every week. Then three pearls will be used for 3 months (one pearl monthly).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohda-Tajrish Hospital
Full name of responsible person
Mahtab Niroumand,Endocrinologist,Assistant professor
Street address
Shahrdari stt, Tajrish squire
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gudarzi H.MD. Vice dean for research
Street address
Next to Ayatollah Taleghani Hospita
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahtab Niroomand
Position
Endocrinologist/Assistant Professor
Other areas of specialty/work
Street address
Next to Ayatollah Taleghani Hospital, Velenjak
City
Tehran
Postal code
1446667316
Phone
+98 21 8826 2390
Fax
Email
m.niroomand@sbmu.ac.ir mahtabniroomand@yahoo.com m_jallili@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahtab Niroomand
Position
Endocrinologist
Other areas of specialty/work
Street address
Next to Ayatollah Taleghani Hospital, Velenjak
City
Tehran
Postal code
1985717443
Phone
+98 21 23871
Fax
Email
m.niroomand@sbmu.ac.ir mahtabniroomand@yahoo.com m_jallili@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahtab Niroomand
Position
Endocrinologist/Assistant Professor
Other areas of specialty/work
Street address
Shohda-Tajrish Hospital
City
Tehran
Postal code
1446667316
Phone
+98 21 8826 2390
Fax
Email
m.niroomand@sbmu.ac.ir mahtabniroomand@yahoo.com m.jallili@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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